FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act.
Nevertheless, because of other public health priorities and a previous lack of evidence of safety concerns, FDA has not traditionally regulated tattoo inks or the pigments used in them.
The real practice of tattooing is regulated by local jurisdictions. FDA is conscious of more than 150 reports of adverse reactions in consumers to certain permanent make-up ink shades, and it is possible that the actual number of women affected was greater.
Also, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks.
FDA keeps on evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. Once new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
Additionally to the reported adverse reactions, areas of concern include tattoo removal, infections that result from tattooing and the increasing variety of pigments and diluents being used in tattooing. More than 50 different pigments and shades are in use, and the list continues to grow. Even though a number of color additives are approved for use in cosmetics, none is approved for injection into the skin.
Using a not approved color additive in a tattoo ink makes the ink adulterated. Lots of pigments used in tattoo inks are not approved for skin contact at all. Some of them are industrial grade colors that are suitable for printers' ink or automobile paint.
However, many individuals choose to undergo tattooing in its various forms. For some people, it is an aesthetic choice or an initiation rite. Then some choose permanent makeup as a time saver or because they have physical difficulty applying regular, temporary makeup. For others, tattooing is an adjunct to reconstructive surgery, particularly of the face or breast, to simulate natural pigmentation.
People who lost their eyebrows due to alopecia (a form of hair loss) may choose to have "eyebrows" tattooed on, while people with vitiligo (a lack of pigmentation in areas of the skin) may try tattooing to help camouflage the condition.
It doesn't matter what their reason, consumers should be aware of the risks involved in order to make an informed decision.